How to Choose a Notified Body
Key Selection Criteria
1. Scope designation (most important) Verify on NANDO that the NB is designated under EU MDR or IVDR for your specific device class and device type. A NB may be designated for medical devices generally but not for your specific product type.
2. Capacity and realistic timelines NB capacity has been significantly constrained since EU MDR transition. For Class III first submissions, plan 18–24+ months from application to certificate. Ask the NB directly for current queue estimates before committing.
3. Experience with your device type NBs develop specialisations (cardiovascular, orthopaedics, IVD, SaMD, active implantables). Ask for examples of similar devices certified. Specialist experience means a more efficient, predictable assessment process.
4. Audit language Confirm availability of auditors in your working language. Most major NBs offer English; some offer German, French, or Italian — particularly relevant for Swiss manufacturers.
5. Swiss market experience While all EU NBs can be used for Swiss market access, NBs with established Swiss market processes can support DAPI registration more smoothly. Ask specifically about their experience with Swissmedic registration submissions.
Finding NBs via NANDO
See NANDO Database for search instructions.
Questions to Ask Potential NBs
- What is your current queue time for my device class?
- Have you certified devices of this type before?
- What languages do your auditors work in?
- Can you provide a letter of intent and preliminary review?
- What are your fees for initial certification and annual surveillance?
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.